FDA.reportPublic FDA data

Levofloxacin

Product NDC
76519-1001
11-digit product format
765191001
Labeler code
76519
Product ID
76519-1001_989e7994-d299-4a68-ae22-259fd0290a3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076361
Marketing category
ANDA
Marketing start
2011-11-22
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1001-12019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
76519-1001-22019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
76519-1001-32019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
76519-1001-42019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
76519-1001-52019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
76519-1001-72019-11-13C16284748780-197449f38-d4d2-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets for oral use Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1001-1Levofloxacin1 in 1 BOTTLETABLET, FILM COATED11
76519-1001-2Levofloxacin2 in 1 BOTTLETABLET, FILM COATED21
76519-1001-3Levofloxacin3 in 1 BOTTLETABLET, FILM COATED31
76519-1001-4Levofloxacin4 in 1 BOTTLETABLET, FILM COATED41
76519-1001-5Levofloxacin5 in 1 BOTTLETABLET, FILM COATED51
76519-1001-7Levofloxacin7 in 1 BOTTLETABLET, FILM COATED71

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LEVOFLOXACINACTIVE MOIETY6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1001LEVOFLOXACIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 6 package rows20120417_398348ed-1b65-4109-9d0f-f9d8a7175d61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN398348ed-1b65-4109-9d0f-f9d8a7175d611
199885levofloxacin 500 MG Oral TabletSCD398348ed-1b65-4109-9d0f-f9d8a7175d611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1001-1765191001011 in 1 BOTTLEHistorical
76519-1001-2765191001022 in 1 BOTTLEHistorical
76519-1001-3765191001033 in 1 BOTTLEHistorical
76519-1001-4765191001044 in 1 BOTTLEHistorical
76519-1001-5765191001055 in 1 BOTTLEHistorical
76519-1001-7765191001077 in 1 BOTTLEHistorical